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EP4585213A3 - Formulations d'amlodipine - Google Patents

Formulations d'amlodipine

Info

Publication number
EP4585213A3
EP4585213A3 EP25170517.4A EP25170517A EP4585213A3 EP 4585213 A3 EP4585213 A3 EP 4585213A3 EP 25170517 A EP25170517 A EP 25170517A EP 4585213 A3 EP4585213 A3 EP 4585213A3
Authority
EP
European Patent Office
Prior art keywords
oral liquid
liquid formulations
amlodipine
amlodipine formulations
formulations
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP25170517.4A
Other languages
German (de)
English (en)
Other versions
EP4585213A2 (fr
Inventor
Scott BRAUER
Gerold L Mosher
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Silvergate Pharmaceuticals Inc
Original Assignee
Silvergate Pharmaceuticals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=61829917&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP4585213(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Silvergate Pharmaceuticals Inc filed Critical Silvergate Pharmaceuticals Inc
Publication of EP4585213A2 publication Critical patent/EP4585213A2/fr
Publication of EP4585213A3 publication Critical patent/EP4585213A3/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
EP25170517.4A 2016-10-07 2017-10-06 Formulations d'amlodipine Pending EP4585213A3 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201662405455P 2016-10-07 2016-10-07
PCT/US2017/055576 WO2018067959A1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine
EP17859269.7A EP3522872B1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine
EP21190149.1A EP3960158B1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine

Related Parent Applications (3)

Application Number Title Priority Date Filing Date
EP21190149.1A Division-Into EP3960158B1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine
EP21190149.1A Division EP3960158B1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine
EP17859269.7A Division EP3522872B1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine

Publications (2)

Publication Number Publication Date
EP4585213A2 EP4585213A2 (fr) 2025-07-16
EP4585213A3 true EP4585213A3 (fr) 2025-10-08

Family

ID=61829917

Family Applications (3)

Application Number Title Priority Date Filing Date
EP21190149.1A Active EP3960158B1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine
EP17859269.7A Active EP3522872B1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine
EP25170517.4A Pending EP4585213A3 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine

Family Applications Before (2)

Application Number Title Priority Date Filing Date
EP21190149.1A Active EP3960158B1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine
EP17859269.7A Active EP3522872B1 (fr) 2016-10-07 2017-10-06 Formulations d'amlodipine

Country Status (5)

Country Link
US (7) US10695329B2 (fr)
EP (3) EP3960158B1 (fr)
CA (1) CA3038989A1 (fr)
ES (2) ES2886067T3 (fr)
WO (1) WO2018067959A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018067959A1 (fr) 2016-10-07 2018-04-12 Silvergate Pharmaceuticals, Inc. Formulations d'amlodipine
US10799453B2 (en) 2018-04-11 2020-10-13 Silvergate Pharmaceuticals, Inc. Amlodipine formulations
CN110372575A (zh) * 2019-07-10 2019-10-25 复旦大学 一种二氢吡啶钙拮抗剂共晶体及其制备方法和应用
WO2021224942A1 (fr) * 2020-05-06 2021-11-11 Alkem Laboratories Ltd. Formes polymorphes de benzoate d'amlodipine et leur procédé de préparation
US11224572B1 (en) * 2020-08-17 2022-01-18 Novitium Pharma LLC Stable oral liquid composition of terazosin
US11452690B1 (en) 2021-01-27 2022-09-27 ECI Pharmaceuticals, LLC Oral liquid compositions comprising amlodipine besylate and methods of using the same
US11253474B1 (en) 2021-02-01 2022-02-22 Liqmeds Worldwide Limited Pharmaceutical solution of amlodipine

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Publication number Priority date Publication date Assignee Title
CN101416966A (zh) * 2007-10-22 2009-04-29 鲁南制药集团股份有限公司 一种治疗高血压的药物组合物
US20110294860A1 (en) * 2008-12-17 2011-12-01 Medrx Co., Ltd. Aqueous oral preparation of stable amlodipine

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DK161312C (da) 1982-03-11 1991-12-09 Pfizer Analogifremgangsmaade til fremstilling af 2-aminoalkoxymethyl-4-phenyl-6-methyl-1,4-dihydropyridin-3,5-dicarboxylsyreestere eller syreadditionssalte deraf samt phthalimidoderivater til anvendelse som udgangsmateriale ved fremgangsmaaden
GB8608335D0 (en) 1986-04-04 1986-05-08 Pfizer Ltd Pharmaceutically acceptable salts
US6057344A (en) 1991-11-26 2000-05-02 Sepracor, Inc. Methods for treating hypertension, and angina using optically pure (-) amlodipine
US6333342B1 (en) 1998-11-04 2001-12-25 Isotechnika, Inc Methods of pharmacological treatment using S(−) amlodipine
CN1100038C (zh) 2000-02-21 2003-01-29 张喜田 氨氯地平对映体的拆分
WO2002053541A1 (fr) 2000-12-29 2002-07-11 Pfizer Limited Derive d'amide d'amlodipine
SI1309555T1 (sl) 2000-12-29 2005-12-31 Pfizer Ltd Postopek izdelave amlodipin-maleata
MXPA03005884A (es) 2000-12-29 2005-04-08 Pfizer Ltd Hemimaleato de amlodipina.
AT5874U1 (de) 2000-12-29 2003-01-27 Bioorg Bv Pharmazeutische zubereitungen enthaltend amlodipinmaleat
CA2433181C (fr) 2000-12-29 2005-11-22 Pfizer Limited Fumarate d'amlodipine
WO2002053540A1 (fr) 2000-12-29 2002-07-11 Pfizer Limited Derive aspartate de l'amlodipine utilise comme antagoniste des canaux calciques
US6653481B2 (en) 2000-12-29 2003-11-25 Synthon Bv Process for making amlodipine
MXPA03005882A (es) 2000-12-29 2005-04-19 Pfizer Ltd Derivado amida de amlodipina.
US6680334B2 (en) 2001-08-28 2004-01-20 Pfizer Inc Crystalline material
BR0213505A (pt) 2001-10-24 2004-10-19 Sepracor Inc Método de resolução de racemato de amlodipina
KR100538641B1 (ko) 2002-07-30 2005-12-22 씨제이 주식회사 암로디핀의 유기산염
KR100496436B1 (ko) 2002-07-30 2005-06-20 씨제이 주식회사 암로디핀의 유기산염
KR100467669B1 (ko) 2002-08-21 2005-01-24 씨제이 주식회사 암로디핀의 유기산염
AU2003253460A1 (en) 2002-09-19 2004-04-08 Cj Corporation Crystalline organic acid salt of amlodipine
CA2559670A1 (fr) 2003-04-14 2004-10-28 Gabor Pragai Formulations ameliorees de maleate d'amlodipine
WO2005079772A2 (fr) 2004-02-18 2005-09-01 Sepracor Inc. Combinaison d'(s)-amlodipine et d'un inhibiteur de l'ace, et procedes pour reduire l'hypertension
WO2005089353A2 (fr) * 2004-03-16 2005-09-29 Sepracor Inc. (s)-amlodipine malate
WO2005099699A1 (fr) 2004-04-07 2005-10-27 Sepracor Inc. Combinaison de (s)-amlodipine et d'un betabloquant, et procedes pour la reduction de l'hypertension
WO2006059217A1 (fr) * 2004-12-01 2006-06-08 Ranbaxy Laboratories Limited Formes posologiques solides stables d'amlodipine bezylate, et procedes d'elaboration correspondants
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GT200600371A (es) * 2005-08-17 2007-03-21 Formas de dosis sólidas de valsartan y amlodipina y método para hacer las mismas
US8158146B2 (en) 2005-09-28 2012-04-17 Teva Pharmaceutical Industries Ltd. Stable combinations of amlodipine besylate and benazepril hydrochloride
EP2023898A1 (fr) 2006-05-10 2009-02-18 Evonik Degussa GmbH Utilisation de dioxyde de silicium produit pyrogéniquement compacte au rouleau dans des compositions pharmaceutiques
EP2032124A1 (fr) 2006-06-27 2009-03-11 Biovail Laboratories International Srl Système de délivrance osmotique multiparticulaire
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CN101843615A (zh) * 2010-06-25 2010-09-29 包丽昕 含有缬沙坦和苯磺酸氨氯地平的分散片及其制备方法
CN102370965A (zh) * 2010-08-11 2012-03-14 南京先宇科技有限公司 一种含有左旋氨氯地平药学上可接受的盐与培哚普利药学上可接受的盐的药物组合物
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* Cited by examiner, † Cited by third party
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CN101416966A (zh) * 2007-10-22 2009-04-29 鲁南制药集团股份有限公司 一种治疗高血压的药物组合物
US20110294860A1 (en) * 2008-12-17 2011-12-01 Medrx Co., Ltd. Aqueous oral preparation of stable amlodipine

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Also Published As

Publication number Publication date
US10695329B2 (en) 2020-06-30
US11364230B2 (en) 2022-06-21
EP3522872B1 (fr) 2021-08-11
US10959991B2 (en) 2021-03-30
US20200338054A1 (en) 2020-10-29
US12053461B2 (en) 2024-08-06
EP3960158C0 (fr) 2025-05-21
ES2886067T3 (es) 2021-12-16
US20220296578A1 (en) 2022-09-22
US10952998B2 (en) 2021-03-23
US20210186942A1 (en) 2021-06-24
EP3960158B1 (fr) 2025-05-21
EP3522872A4 (fr) 2020-05-20
EP3960158A1 (fr) 2022-03-02
US20200338055A1 (en) 2020-10-29
US20180098978A1 (en) 2018-04-12
US20200246320A1 (en) 2020-08-06
EP4585213A2 (fr) 2025-07-16
US20240390347A1 (en) 2024-11-28
EP3522872A1 (fr) 2019-08-14
US12336984B2 (en) 2025-06-24
WO2018067959A1 (fr) 2018-04-12
US10894039B2 (en) 2021-01-19
CA3038989A1 (fr) 2018-04-12
ES3035030T3 (en) 2025-08-28

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